2-day In-person Seminar on Regulatory Compliance for Dietary Supplements in the US, EU and Canada at Boston
A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States, EU and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in these countries.
View this email in your browser | Unsubscribe from future mailings 2-day In-person Seminar on Regulatory Compliance for Dietary Supplements in the US, EU and Canada Course "Regulatory Compliance for Dietary Supplements in the US, EU and Canada " has been pre-approved by RAPS as Register Now eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Date & Time: Instructor Profile: September 13th and 14th 2012 8 AM to 5 PM EDT James E. Russell Duration: 2 Days Instructor: James E. Russell Director of Regulatory Affairs, RJR Consulting Inc Price : $1495.00 (for one Location: Boston participant) Mr. Russell is the Director of Register for 4 Participants to Get 1 Free Pass Regulatory Affairs and Business Development for RJR Consulting Inc, a leading global regulatory consulting firm servicing the Life Overview: Science and Consumer Products A growing public demand for supplements has resulted in a flurry of industries. Mr. Russell has 13 years companies creating and marketing dietary supplements in the United of experience in the Life Science States, EU and Canada. With the regulatory authorities beginning to field, encompassing foods, dietary take a stronger stance on enforcement of regulatory policies, supplements, medical devices and pharmaceuticals. James joined RJR procedures and GMP compliance, it is important for companies to Consulting in 2009 to assist verify that their products comply with the latest regulations and companies with their global provisions if they plan to market Supplements in these countries. regulatory, manufacturing and distribution needs. This 2-day interactive live seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada and discuss Prior to RJR, Mr. Russell worked for how to verify that products are compliant with these regulations. a large life science distribution Differences with food and drug regulation in these countries will be company with organizational responsibilities including regulatory, noted as well. We will also cover what qualifies as a dietary supply chain, business strategy and supplement or dietary ingredient, how to ensure GMP compliance as product data quality. Mr. Russell well as detailed requirements for labeling and acceptable marketing currently teaches on a variety of claims. An update on current events within the Supplement industry regulatory topics and is a and the potential impacts to Manufacturers and Distributors in the participating member of the US, EU and Canada will also be presented and discussed. Regulatory Affairs Professionals Society (RAPS). ...more Course Outline: Suggest a Topic More Webinars Course Outline: Day 1: Your Necessity is our Priority Dietary Supplement Regulation in the U.S. Lecture 1: Dietary Supplement Overview l What is a dietary supplement? l Supplements vs. ¡ Pharmaceuticals ¡ OTC Drugs ¡ Conventional Foods ¡ Medical foods ¡ Natural products ¡ Herbal medicinal products Lecture 2: Organizations and Regulatory Structure l FDA Structure regarding Dietary Supplements l Industry Groups Lecture 3: History of Dietary Supplement Regulation l Early History l DSHEA l Code of Federal Regulations Lecture 4: Manufacturing Considerations l Company & Facility Registration l GMP Requirements l GMP inspections Lecture 5: Dietary Ingredients l What qualifies as a dietary ingredient? l Old dietary ingredients vs. New dietary ingredients l New Dietary Ingredient Notification (NDIN) l Updated New Dietary Ingredient Guidance from FDA Lecture 6: Labeling Considerations l Display Panels & Layout l Supplement Facts Panel l Labeling Claims ¡ Health claims ¡ Disease Claims ¡ Structure/Function claims ¡ Disclaimers/Substantiation l Notification of labeling claims to FDA l Dietary Supplement Labeling Act Lecture 7: Advertising Considerations l FDA vs. FTC jurisdiction l Enforcement l Expressed vs. Implied Claims ¡ Exercises & examples l Disclosures l Claim Substantiation l Testimonials Course Outline: Day 2: Food Supplement regulation in the EU Lecture 8: Overview l What is a food supplement? l Borderline products l Medicinal Foods Lecture 9: Organizations and Regulatory Structure l EU Regulatory Structure l Industry Groups Lecture 10: Supplement Regulation l Early History l Food Supplement Directive Lecture 11: Manufacturing Considerations l Company & Facility Registration l GMP Requirements Lecture 12: Dietary Ingredients l What qualifies as a dietary ingredient? l Ingredient safety l RDA vs RDI l DRV vs % Daily Value Lecture 13: Labeling Considerations l Display Panels & Layout l Labeling Claims ¡ Health claims ¡ Disease Claims ¡ Reduction of Disease Risk Claims ¡ Nutrition Claims l Notification requirements Lecture 14: Advertising Considerations l Enforcement l Claim Substantiation Natural Health Product regulation in Canada Lecture 15: Overview l What is a Natural Health Product? Lecture 16: Organizations and Regulatory Structure l Canadian Regulatory Structure ¡ Health Canada ¡ Canadian Health Products Directorate Lecture 17: Supplement Regulation l National Health Products Regulation l Differences between Canada and US l Supplements monographs l Requirements for pre-market approval Lecture 18: Manufacturing Requirements for Natural Health Products in Canada Lecture 19: Dietary Ingredients Lecture 20: Labeling Considerations Lecture 21: Advertising Considerations Lecture 22: Enforcement and Post-Marketing Surveillance Click here to register for this seminar Who Will Benefit: l Executives/Managers within Dietary Supplement or Natural Product companies l Regulatory Compliance Professionals in the Supplements or Natural Products area l Quality Assurance or Quality Control Professionals l Dietary Supplement or Natural Product Manufacturers & Distributors l Sales/Marketing Personnel in the Supplement or Natural Product Industries It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. 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